By Norma Erickson, President
2 September 2011, SANE Vax Inc. posted a letter sent to Dr. Margaret Hamburg, FDA Commissioner, on their website to inform her that recombinant (genetically modified) HPV DNA firmly attached to the aluminum adjuvant had been discovered in Merck’s quadrivalent HPV vaccine, Gardasil™.
In what appears to be a worldwide coordinated response, SANE Vax Inc. and other advocacy groups have received the following replies:
- 22 September 2011, the European Medicines Agency, via Dr. Abadie said, “The presence of recombinant DNA fragments does not represent a case of contamination and is not considered to be a risk to vaccine recipients. All medicinal products manufactured using recombinant technology may contain small fragments of residual DNA.”
- 23 September 2011, the Food and Drug Administration (FDA) said, “We have determined that Gardasil is not contaminated with HPV DNA and remains safe and effective….Gardasil does contain recombinant HPV L1 specific DNA fragments. This is expected, since DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles. The presence of these expected DNA fragments, which are inevitable in vaccine production, is not a risk to vaccine recipients, is not harmful, and this DNA is not a contaminant.”
- 28 September 2011, MedSafe in New Zealand, via email to a local vaccine safety advocate said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
- 7 October 2011, the Queensland Immunisation Program in Australia, via email to an Australian advocate, said, “Gardasil is manufactured using recombinant DNA technology so any finding of residual DNA fragments in the vaccine is expected and does not represent contamination.”
The above statements are all in direct contradiction to the following documentation used on a world-wide basis to either approve, and/or market Gardasil™:
- From the United Kingdom: HPV vaccines are sub-unit vaccines made from the major protein of the viral-coat or capsid of HPV.Virus-like particles (VLPs) are prepared as recombinant proteins from either yeast or baculovirus infected cells that are derived from a type of moth. VLPs mimic the structure of the natural virus but do not contain any viral DNA.
- From the FDA: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
- From Australia: “GARDASIL contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a unique recombinant L1 major capsid protein for the respective HPV type. Because the virus-like particles contain no viral DNA, they cannot infect cells or reproduce.”
- From the Gardasil Access Program: “GARDASIL® is not a live virus vaccine; it contains no viral DNA, and is therefore incapable of causing infection.”
To date, all health agencies responding to the SANE Vax announcement of Gardasil™ contamination have completely ignored the fact that the residual HPV DNA is firmly attached to the aluminum adjuvant. Furthermore, no regulatory authority, anywhere, has asked to see the detailed genetic sequences contained in the laboratory results, in order to ask their own laboratories to confirm the Genbank DNA sequences found.
It is important to note that every single time the SANE Vax team communicates with any health ‘authority’ our claims are backed up and referenced with peer-reviewed published scientific studies, data from the manufacturer, or data from government sponsored health agencies. When a response is received, there is no evidence to back up the health agency’s position.
Where does this leave medical consumers? Medical consumers around the world are no longer satisfied with a simple ‘pat on the head’ and ‘assurances’ that vaccines are safe and effective. They demand and deserve scientific proof.
If parents of the Gardasil™ victims had been fully informed of all the risks and limited benefits of Gardasil™, including the presence of recombinant DNA in the vaccine which may cause autoimmune-based disorders, immediate death, or permanent disabilities, they might have been able to make an informed decision. They could have made an informed choice as to whether it was better for their children to risk immediate negative outcomes with a vaccine, or to teach their children about an already proven safe and effective method of controlling cervical cancer, namely regular screening and good gynecological care.
It is time for the manufacturers of HPV vaccines and government health agencies involved to provide scientifically sound proof that residual recombinant HPV DNA firmly attached to an aluminum adjuvant presents no current or future health risk to the children and young adults of the world.
When injecting a healthy population to attempt to control a disease that may occur 40 years down the road in a population that has limited or no access to good gynecological care, there is no excuse for taking on any additional risk involved with vaccination.
Until such time as documented scientific proof is provided, all potentially contaminated vaccines should be withdrawn from the market. Anything less deprives parents around the world of their right to informed consent when making healthcare decisions for their children.